Rebecca Willumson (00:10):
Hi there, I'm Rebecca Willumson. I'm the publisher of Fierce Biotech, and I'm here today with James Park, Executive VP and Chief Business Officer at Samsung Biologics. James, thanks so much for joining me today.
James Park (00:20):
Oh, thank you. Thanks for having me.
Rebecca Willumson (00:20):
Now James, before we begin, could you tell me a little bit about yourself and your role at Samsung Biologics?
James Park (00:27):
Yeah. My name's James Park, I lead the global sales and operations—I'm the Chief Business Officer at Samsung Biologics. I've been with Samsung Biologics for six plus years. Prior to joining Samsung Biologics, I was at Bristol-Myers-Squibb, Merck MSD, as well as Janssen.
Rebecca Willumson (00:47):
Now, mRNA vaccines are drawing a lot of attention from the global pharmaceutical industry. Tell me, what is Samsung Biologics' mRNA vaccine manufacturing business status? And tell me a little bit about its future plans.
James Park (01:00):
Sure. As you know, with this pandemic, there's a global demand for mRNA vaccines. Samsung Biologics has monoclonal antibody production facilities at [our facilities in] Songdo. However, we want to venture into mRNA technology as well. So starting in April of 2021, we built the capability on the drug substance side of the mRNA vaccine and manufacturing, and we will have the DS facility ready by Q2 2022.
James Park (01:31):
However in the meantime, we're supporting the mRNA production for the global patients by fill-finishing Moderna’s vaccine. We contracted DP services in May of 2021, did a tech transfer within three months, and we started manufacturing in September of 2021. We'll continue to manufacture the fill-finish of the drug product, we call it, for the Moderna vaccine.
James Park (01:59):
We are building our capability end-to-end from an mRNA perspective. We have a strong quality control organization, and the analytical capabilities for release testing of the mRNA vaccines. And also, we are building the capability for drug substance.
James Park (02:18):
We're going to have end-to-end services from drug substance manufacturing all the way up to fill-finish, and labeling and packaging. Because of those capabilities that we have in the mRNA vaccine, we recently released public information, announcing that we have contracted with Greenlight Biosciences. It's a company in Massachusetts who we will develop and manufacture their drug substance in the near future.
Rebecca Willumson (02:47):
Very good. Now there have been several announcements about Samsung Biologics' expansion plans in South Korea. Can you tell me, does Samsung Biologics have any plans to expand overseas?
James Park (02:58):
Yeah, absolutely. Obviously for the last 10 years, we have cemented our monoclonal antibody production facility in Songdo, Korea. However, we're always looking to expand to potentially where the clients are in the US and Europe. We started doing that in 2020 actually. We have an R&D Center, which is a contract development services office in San Francisco. So, we started that to venture and expand into the US in October 2020. We are going to continue to expand to other biotech hubs in the United States, such as in the Boston area for example, and then also potentially to Europe and China in the future.
James Park (03:45):
But from the CMO perspective, a large-scale manufacturing perspective, we are continuing to evaluate the need for expanding into the US or Europe. So again, hopefully within the next year or two, we will have the opportunity to announce that we will expand into other geographical areas other than our Songdo facility.
Rebecca Willumson (04:08):
So to kind of wrap up our conversation a little bit, tell me, what would you consider Samsung Biologics' primary strength as a CDMO?
James Park (04:16):
I think our primary strength is speed and execution excellence. Again, our Samsung DNA is all about speed and execution, with quality in mind. So, I think one example is our EPCV, which stands for engineering, procurement, construction and validation. We’ve been building our plants every two and a half years, and we are currently building plant number four. Compared to our competitors, it takes a much shorter time: two and a half years [for us] versus four plus years for our competitors.
James Park (04:49):
So I think having that know-how in terms of building the plants sooner actually helps in time, value and money as well. Also, the execution. I mean, we've been manufacturing 47 products and beyond for our customers. Ultimately, it's for the patients in the world. So, we're very proud of our execution excellence as well as speed to get the product on the market for our clients and ultimately to the patients.
Rebecca Willumson (05:20):
Well, that's great. Now James, before we close out, is there anything that you'd like to add to our conversation?
James Park (05:26):
Yeah, one thing I would like to add is right now we have our facility in Songdo. We provide end-to-end service at one location, which I think helps our customers, the value chain in terms of getting product here on the DS, DP, labeling and packaging, and testing—all in one place. It helps from the customer perspective, from their value chain. So, we are very proud of that.
Rebecca Willumson (05:52):
Well that's very good. I think that's a great place to end. James, thank you so much for joining me. I really enjoyed our conversation.
James Park (05:58):
No, thank you again for having me.
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